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Weekly Legislative & Regulatory Round-up

Week of October 24 - 30

GAO reports

Recovery Act: Preliminary Observations on the Implementation of Broadband Programs GAO-10-192T

Influenza Pandemic: Key Securities Market Participants Are Making Progress, but Agencies Could Do More to Address Potential Internet Congestion and Encourage Readiness GAO-10-8

OIG reports

Review of the Department of Health and Human Services’ Process for Performing Limited Data-Quality Reviews of Information Reported by Recipients of Recovery Act Funds (A-09-09-00113)

Health Care Fraud and Abuse Control Program Report: Fiscal Year 2008 

Adverse Event Reporting for Medical Devices (OEI-01-08-00110) 

Beneficiary Appeals in Medicare Advantage (OEI-01-08-00280) 

Bills introduced
Number/
Title
Date Introduced Sponsor Description
H.R. 3925 10/26/09 JIM MCDERMOTT (D-WA) A bill to amend the Employee Retirement Income Security Act of 1974 to preclude preemption of a State cause of action relating to a denial of a claim for benefits under a health care plan; Referred to the Committee on Education and Labor.
H.R. 3932 10/27/09 JOE BARTON (R-TX) A bill to expand the authority of the Secretary of Health and Human Services to impose debarments in order to ensure the integrity of drug, biological product, and device regulation, and for other purposes; Referred to the Committee on Energy and Commerce.
H.R. 3937 10/27/09 LEE TERRY (R-NE) A bill to establish a health benefits program, based on the Federal employees health benefits program, to provide health insurance coverage for the President, Vice President, and Members of Congress, and citizens not eligible for coverage under the Federal employees health benefits program; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Oversight and Government Reform, Education and Labor, and Ways and Means
H.R. 3955 10/28/09 CHRISTOPHER CARNEY (D-PA) A bill to amend the Public Health Service Act to authorize grants to 10 States for demonstration projects for the expansion of State registries on childhood immunization or health to include data on body mass index (BMI), collected and submitted to the State by health care providers; Referred to the Committee on Energy and Commerce.
 H.R. 3 10/29/09 JOHN DINGELL (D-MI) A bill to amend title XVIII of the Social Security Act to reform the Medicare SGR payment system for physicians; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.
 H.R. 3962   JOHN DINGELL (D-MI) A bill to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and Labor, Ways and Means, Oversight and Government Reform, the Budget, Rules, Natural Resources, and the Judiciary
H.R. 3970   MARK KIRK (R-IL) A bill to protect the doctor-patient relationship, improve the quality of health care services, lower the costs of health care services, expand access to health care services, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, Ways and Means, Education and Labor, Appropriations, and Financial Services
 H.R. 3971   JEFF FLAKE (R-AZ) A bill to amend the Internal Revenue Code of 1986 to expand the permissible use of health savings accounts to include health insurance payments and to increase the dollar limitation for contributions to health savings accounts, and for other purposes; Referred to the Committee on Ways and Means.
 H.R. 3974   MICAHEL HONDA (D-CA) A bill to amend the Public Health Service Act to direct the Secretary of Health and Human Services to establish, promote, and support a comprehensive prevention, education, research, and medical management referral program for viral hepatitis infection that will lead to a marked reduction in the disease burden associated with chronic viral hepatitis and liver cancer; Referred to the Committee on Energy and Commerce.


 

October 26

No relevant notices.

 

October 27

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Prescription Drug User Fee Rates for Fiscal Year 2010; Correction

ACTION: Notice; correction.

 

Food and Drug Administration

Emerging Arboviruses: Risk Assessment for Blood, Cell, Tissue,

and Organ Safety; Public Workshop

ACTION:  Notice of public workshop.

 

Food and Drug Administration

Saccharomyces boulardii Eligibility for Consideration To Be Added

to the Over-the-Counter Drug Monograph for Antidiarrheal Drug Products;

Request for Safety and Effectiveness Data; Withdrawal

ACTION: Withdrawal of notice of eligibility and request for data and

information.

 

October 28

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Agency Information Collection Activities: Submission for OMB

Review; Comment Request

1. Type of Information Collection Request: Revision of a currently

approved collection; Title of Information Collection: Medicare Parts C

and D Universal Audit Guide

 

October 29

No relevant notices.

 

October 30

 DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

 

Medicaid Program: State Flexibility for Medicaid Benefit Packages

and Premiums and Cost Sharing

ACTION: Proposed Rule.

SUMMARY: This document proposes to temporarily delay the effective date

of the November 25, 2008 final rule entitled, ``Medicaid Program;

Premiums and Cost Sharing'' and the December 3, 2008 final rule

entitled, ``Medicaid Program; State Flexibility for Medicaid Benefit

Packages.'' Upon the review and consideration of the new provisions of

the American Recovery and Reinvestment Act of 2009, the Children's

Health Insurance Program Reauthorization Act of 2009, and the public

comments received during the reopened comment period, we believe that

it is necessary to revise a substantial portion of the November 25,

2008 and the December 3, 2008 final rules. To allow time to make these

revisions, the Department has determined that it needs several more

months to revise the rule. Accordingly, we are asking for public

comment on this proposal for delaying the effective date of the final

rules until July 1, 2010.

DATES: To be assured consideration, comments must be received at one of

the addresses provided below, no later than 5 p.m. on November 19,

2009.

 

Centers for Medicare & Medicaid Services

Agency Information Collection Activities: Proposed Collection;

Comment Request

1. Type of Information Collection Request: Extension of a currently

approved collection; Title of Information Collection: Eligibility Error

Rate Measurement in Medicaid and the Children's Health Insurance

Program

 

Centers for Medicare & Medicaid Services

Agency Information Collection Activities: Submission for OMB

Review; Comment Request

1. Type of Information Collection Request: Revision of the

currently approved collection; Title of Information Collection: State

Medicaid Eligibility Quality Control (MEQC) Sample Selection Lists and

Supporting Regulations in 42 CFR 431.800-431.865

 

Centers for Medicare & Medicaid Services

Medicare Program; Meeting of the Practicing Physicians Advisory

Council, December 7, 2009

ACTION: Notice.

DATES: Meeting Date: Monday, December 7, 2009, from 8:30 a.m. to 5

p.m., eastern standard time (e.s.t.).

ADDRESSES: Meeting Location: The meeting will be held in Room 505A, in

the Hubert H. Humphrey Building, 200 Independence Avenue, SW.,

Washington, DC 20201.

 

Office of the Secretary

HIPAA Administrative Simplification: Enforcement

ACTION: Interim final rule; request for comments

SUMMARY: The Secretary of the Department of Health and Human Services

(HHS) adopts this interim final rule to conform the enforcement

regulations promulgated under the Health Insurance Portability and

Accountability Act of 1996 (HIPAA) to the effective statutory revisions

made pursuant to the Health Information Technology for Economic and

Clinical Health Act (the HITECH Act), which was enacted as part of the

American Recovery and Reinvestment Act of 2009 (ARRA). More

specifically, this interim final rule amends HIPAA's enforcement

regulations, as they relate to the imposition of civil money penalties,

to incorporate the HITECH Act's categories of violations, tiered ranges

of civil money penalty amounts, and revised limitations on the

Secretary's authority to impose civil money penalties for established

violations of HIPAA's Administrative Simplification rules (HIPAA

rules). This interim final rule does not make amendments with respect

to those enforcement provisions of the HITECH Act that are not yet

effective under the applicable statutory provisions. Such amendments

will be subject to forthcoming rulemaking(s).

DATES: Effective Date: This interim final rule is effective November

30, 2009. Comment Date: Comments on this interim final rule will be

considered if received at the appropriate address, as provided below,

no later than December 29, 2009.

 

Centers for Disease Control and Prevention

Total Inward Leakage Requirements for Respirators

ACTION: Notice of proposed rulemaking.

SUMMARY: The Centers for Disease Control and Prevention (``CDC'')

proposes to establish total inward leakage (TIL) requirements for half-

mask air-purifying particulate respirators approved by the National

Institute for Occupational Safety and Health (``NIOSH'') of CDC. The

proposed new requirements specify TIL minimum performance requirements

and testing to be conducted by NIOSH and respirator manufacturers to

demonstrate that these respirators, when selected and used correctly,

provide effective respiratory protection to intended users against

toxic dusts, mists, fumes, fibers, and biological and infectious

aerosols (e.g. influenza A(H5N1), severe acute respiratory syndrome

(SARS) coronavirus, and Mycobacterium tuberculosis).

DATES: CDC invites comments on this proposed rule from interested

parties. Comments must be received by December 29, 2009.

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